Problem Solving / Problem Avoidance with a Flow Chart

As a consultant, I'm frequently called upon to do CGMP inspections / audits, and/or review or write SOPs.  One of the most frequent US FDA 483 Observation is for company personnel found not following their own SOPs.  How to minimize?

With any SOP I'm auditing or writing, I start with a simple flow chart.  For an existing SOP, I'll flow chart (or try to) the written sequence described.  Often, I can't complete the chart because there is no "flow".  Whoever wrote the SOP did not visit the shop floor, or carefully observe the steps involved in an operation, or replicate the steps themselves, or similar.  And then the company wonders why the SOP isn't followed, or choses to blame the operator for not following or changing the steps outlined in order to do their job (see Dr. Deming  for who's really responsible for this non-conformance / CGMP major violation - the operator or management). 

Whenever I have to write an SOP, I'll observe the actual work / operation being performed, and/or try to duplicate it myself, and then flow chart each key step. Then I write the SOP following the flow verified by the flow chart. I will then usually include a simplified version of the flow chart in the SOP!

Such use of a simple tool, the flow chart, will find problems in existing SOPs (and systems) or prevent their occurrence in SOPs / systems under development.

- jel@jelincoln.com  

Updated 06/20/2022 - JEL